Bipartisan letter urges effective administration of 340B program

House Energy and Commerce Committee Chairman Greg Walden, R-Ore., Energy and Commerce Committee Ranking Member Frank Pallone, Jr., D-N.J., Senate Health, Education, Labor, and Pensions Committee Chairman Lamar Alexander, R-Tenn., and Senate HELP Committee Ranking Member Patty Murray D-Wash., Aug. 27 sent a letter to the Health Resources and Services Administration urging the agency to use its existing rulemaking authority to implement regulations to better administer the 340B drug savings program. “The [D.C. District] court ruling made clear that HRSA does have regulatory authority that includes (1) establishing and implementing a binding Administrative Dispute Resolution process for the resolution of certain disputes relating to compliance with 340B Program requirements, (2) providing for the imposition of civil monetary penalties against manufacturers that knowingly and intentionally overcharge a covered entity for a 340B drug, and (3) issuing precisely defined standards of methodology for calculation of 340B ceiling prices,” the leaders wrote.